NEEDHAM, Mass., & PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Tyrogenex, a privately held company focused on the development of targeted therapeutics for cancer and ophthalmology, today announced data from its phase 1 open-label study of orally-administered X-82 in patients for wet age-related macular degeneration (AMD). This data were presented today during the 15th EURETINA Congress in Nice, France.
“Wet AMD is a leading cause of blindness and may require patients to receive injections for treatment,” said Tim Jackson, PhD, FRCOphth, an ophthalmologist at the School of Medicine, King’s College London. “Providing patients with an oral treatment option for wet AMD has the potential to meet an unmet need.”
X-82 is an orally administered, dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) in development for treatment of wet AMD and solid tumors.
The open-label phase 1 study tested X-82 in 35 adult patients with wet AMD to evaluate safety and preliminary efficacy. Six treatment regimens at four dose levels of X-82 were evaluated. The outcomes showed an overall trend toward higher visual acuity of +4.3 letters of the Early Treatment Diabetic Retinopathy Study chart, and a trend toward decreased foveal thickness of -48 µm at 24 weeks (average of all patient data up to injection or dropout). Of the 25 patients completing 24-weeks on X-82, 15 required no intravitreal injections of anti-VEGF and had a mean visual acuity improvement of +5.3 letters. X-82 was generally well tolerated, with 25 of 35 patients completing the full 24-week treatment period.
“The results of this early study are encouraging, and I am delighted that X-82 will now enter phase II studies. Subject to confirmatory studies, the possibility of a pill for wet AMD will be welcomed by the large number of patients who otherwise require repeated eye injections to control their disease,” said Dr. Jackson.
“X-82 is the only orally-administered therapeutic in development for wet AMD. We are encouraged that the Phase 1 data demonstrated the potential of X-82 in filling an unmet need in the wet AMD patient population. We look forward to learning more information from the Phase 2 trials,” said Michael D. Webb, Tyrogenex President and CEO.
Phase 1, open-label, dose-escalation trial performed to evaluate the safety study and preliminary efficacy of X-82 in 35 adult patients. Preliminary efficacy was assessed by evaluation of best-corrected visual acuity (BCVA), change from baseline in central retinal thickness and area of choroidal neovascularization based on fundus examination, fundus photography, fluorescein angiography and optical coherence tomography (OCT). Safety was assessed with evaluating the number and percentage of adverse events.
About Wet AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely "dry" and "wet" AMD. Wet AMD is characterized by the growth of new blood vessels into the central region of the retina. These new and abnormal blood vessels cause severe central vision loss due to retinal damage caused by leakage of the blood vessels and subsequent scar formation.
Tyrogenex’s lead compound is X-82. X-82 inhibits both VEGF and PDGFR. Tyrogenex believes X-82 targets the basic mechanisms of neovascular eye diseases, including angiogenesis, fibrosis and inflammation. X-82 is currently in being evaluated for Wet AMD and Solid Tumors.
Tyrogenex is a biopharmaceutical company focused on improving the lives of patients with Wet AMD and Solid Tumors by discovering medicines to help provide additional treatment options. Tyrogenex’s lead compound is X-82.
For more information, visit www.tyrogenex.com
This press release contains forward-looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.